Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle— 510(k) K232950

Substantially Equivalent

Perfect Medical Industry (Vn) Co., Ltd.

FDA 510(k) clearance K232950 for Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle, Substantially Equivalent on 2024-06-12. Applicant: Perfect Medical Industry (Vn) Co., Ltd..

Clearance details

Applicant: Perfect Medical Industry (Vn) Co., Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2023-09-20
Decision date: 2024-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ho Chi Minh City, VN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.